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21,367 catalysts · 4,728 grant · 3,890 device 510k · 3,086 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
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21,367 catalysts · 4,728 grant · 3,890 device 510k · 3,086 8k filing · 3,063 approval · 2,000 device pma · 2,000 device recall
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DQO. Advisory committee: Cardiovascular. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: LDF. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: CHARTWELL RX. Form: SYRUP. Route: ORAL
Product code: HGM. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: QNM. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NFO. Advisory committee: Neurology. Type: Traditional
Product code: MQK. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: GKZ. Advisory committee: Hematology. Type: Dual Track
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: QKB. Advisory committee: Radiology. Type: Special
Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Sponsor: STRIDES PHARMA. Form: CAPSULE. Route: ORAL
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: BTA. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: NATCO PHARMA LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 — Reason: Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. — Status: Terminated
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. — Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit — Status: Terminated
Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 — Reason: cGMP Deviations: Product intended for quarantine was inadvertently distributed. — Status: Ongoing
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, RX Only, Product of Japan, Distributed by: Astellas Pharma US Inc., Northbrook, IL 60062, NDC 0469-0647-73. — Reason: Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules — Status: Ongoing
Product code: OLP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: IPF. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: KINDOS. Form: INJECTABLE. Route: INJECTION
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FTC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional